Trust Board Meeting : Wednesday 13 November 2013 TB2013.135 Title

Trust Board Meeting : Wednesday 13 November 2013
Research & Development Annual Report 2012/13
For Information
This is an annual report to the Trust Board.
Board Lead(s)
Professor Edward Baker, Medical Director
Key purpose
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Executive Summary
1. The BRC and BRU are in the second year of work since their renewals, and will
undertake a detailed review of progress and future direction during 2014, in order to
prepare for the next NIHR funding round. This is expected to be announced in 2016.
2. The BRC Working Groups have made important progress in a number of key areas.
Molecular Diagnostics and Clinical Informatics have achieved notable early successes,
but require strategic prioritisation if they are to achieve nationally leading success for
the OUH/OU Partnership. BRC Translational Pathology is the focus of a fundamental
3. Mandatory reporting of clinical research performance metrics to NIHR has been
introduced over the last year, highlighting the need to accelerate clinical study initiation
and recruitment. Sustained improvements in OUH performance will require increased
strategic and operational support of clinical research across the OUH Divisions and OU
Clinical Departments. The recent reconfiguration of the OUH Divisions provides an
opportunity to prioritise clinical research performance within the organisation.
4. The Joint Research Office, comprising over 80 members of staff from both OUH and
OU, supports all joint research across the partnership, currently including more than
1200 clinical studies and dealing with over 2000 research contracts annually.
5. Clinical Research plays an important role in strategic developments including the
AHSN, the AHSC bid and recent successes in award of an NIHR CLAHRC, and
designation of OUH as host of the new NIHR Local Clinical Research Networks
(LCRN) for the Thames Valley and South Midlands. Currently the CLRN is ranked 3rd
in England for commercial study performance and 5th for network recruitment, with
OUH itself being the second highest recruiting trust in the country.
6. Recommendation
The Trust Board is asked to receive the report and note the contents.
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BRC and BRU Progress
1.1 During the first year of the post-renewal BRC programme, the 14 Research
Themes and 7 Working Groups have established and consolidated their
programmes. All of the Themes and Working Groups reported on progress, and
milestones achieved, at a review by the BRC Steering Committee on 24th April
2013. This review, and examples of research successes drawn from the Themes’
reports, formed the basis of the BRC annual report to NIHR submitted in May
2013. NIHR feedback on the annual report was satisfactory.
1.2 All BRC Themes have been supported in continuing with their research
programmes through 2013/2014, dependent upon satisfactory review of progress
by the Steering Committee. However, in 2014 there will be a more strategic
review of BRC Themes, incorporating external scientific advice, in order to identify
the new priorities for the Themes. This will be a full two years before the
anticipated submission of the bid in the next round of competitive BRC funding,
expected in 2016 for initiation in 2017.
1.3 The musculoskeletal BRU, based at the Nuffield Orthopaedic Centre, has
established themes in the areas of rheumatology and inflammatory joint disease;
orthopaedics, surgical innovation and evaluation; epidemiology and disease
prevention; sarcoma; and rehabilitation. Notably, the BRU is developing and
evaluating novel surgical and tissue engineering therapies (with filed patents) and
is working closely with the BRC in establishing a Trials Unit supported by the
Royal College of Surgeons (SITU). Work is on-going to align tissue banking and
bioresources. Professor Sallie Lamb (previously Director of the Warwick CTU)
has been recruited to lead a programme in trials of rehabilitation. The BRU away
day and review is scheduled for 18 November 2013.
Developing strategic priorities through the BRC Working Groups and other
2.1. The BRC Working Groups were established to identify and support areas of new
strategic priority for the OUH-OU partnership, in areas including molecular
diagnostics, clinical informatics, clinical trials units, cognitive health,
transplantation, education and training and patient involvement. Of these working
groups, two have made particular progress in the early steps towards establishing
new programmes of activity. However, this initial operational progress has
highlighted a pressing need to agree the strategic objectives. The Board is asked
to specifically consider two areas, Clinical Informatics, and Molecular Diagnostic
and Pathology.
Clinical Informatics:
2.2. Better use of clinical patient-related data, gathered through EPR systems, is critical
to underpinning clinical research programmes, particularly across distributed
clinical pathways and networks. The BRC has made initial investments in
providing leadership. Professor Jim Davies, Department of Computer Science, is
Chairman of the BRC Clinical Informatics Working Group and has been co-opted to
the BRC in a 0.5WTE role as the BRC Director of Clinical Informatics, in
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conjunction with the OU Department of Computer Science. The Clinical
Informatics Working Group brings together investigators who have already
established clinical research programmes that entrain clinical data sets. Greater
investment will be needed to achieve more effective use of clinical data to support
research. It is likely that further additions to lead clinical informatics across specific
therapeutic areas in the OUH-OU Partnership, and across the AHSN, will be
required, complemented by technical and operational changes within the
respective EPRs.
2.3. The NIHR Health Informatics Collaborative (NIHR HIC) has been funded by NIHR,
against the proposal submitted by the Chief Executives of the 5 large BRC Trusts
in Summer 2012. Each of the five BRC Trusts has received £400k revenue and
£400k capital per year for two years to develop systems and governance
frameworks to share clinical data between the BRC Trusts in support of clinical
research programmes in a number of exemplar areas. The OUH-OU Partnership
supports leadership aspects of the NIHR HIC, by hosting the Programme Manager
and the Director of Informatics (Prof. J Davies) who has coordinated the
collaborative programme. The work of the NIHR HIC has been successful in
establishing 5 themes of data collection and sharing across the 5 large BRCs, to
support clinical research. Each theme is led by one of the BRCs- Cancer (Ovarian)
[Cambridge]; Transplantation [Guys/St. Thomas’]; Intensive Care [UCLH]; Acute
Coronary Syndromes [Imperial] and Hepatitis C [Oxford].
2.4. The work of the NIHR HIC is particularly relevant to the developments in genomics,
both locally and nationally. Genomics England (GeL), a company set up with the
Department of Health to run the 100,000 genomes programme, has enlisted
support from the NIHR HIC, and in particular from Oxford, to assist with early set
up, at the request of the Chief Medical Officer and from Sir John Chisholm (the
CEO of GeL).
Molecular Diagnostics and Pathology:
2.5. The BRC Molecular Diagnostics Working Group has built on previous programmes
established by the Blood Theme and Genomic Medicine Theme to establish an
increasing number of clinical diagnostic tests based on genomic technologies
particularly in haematology and oncology. A substantial volume of diagnostic
testing to support both NHS clinical activity and clinical trials is being delivered
through a CPA accredited molecular diagnostic laboratory, the Oxford Molecular
Diagnostics Centre, hosted within the Laboratory Medicine Directorate of the OUH
based at the John Radcliffe and at the Churchill Hospital. In addition to substantial
BRC funding, the molecular diagnostics laboratory is supported by competitive
external grant income from the Technology Strategy Board and from the Health
Innovation Challenge Fund (HICF). The future growth of the Molecular Diagnostics
Centre, beyond a proof of concept that has already been achieved, will be
dependent upon an appropriate business model that reflects the need for flexible
recruitment of staff, the need to direct revenues towards growing new areas of
activity, and the differences that arise from specialised diagnostic testing
underpinning regional and national patient referral pathways, and specialist clinical
trials, as distinct from large volume routine diagnostic testing, e.g. in haematology
and biochemistry.
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2.6. The success of molecular diagnostics is also critically dependent upon support
from Pathology, in order to provide and process cellular and tumour material from
patients, for molecular diagnosis. Attempts to ensure that molecular diagnostics
and clinical research are supported by Pathology have so far not proven to be
effective. The BRC supported the creation of a new post of Director of
Translational Pathology three years ago, but this has not had a major systematic
effect on Pathology support of molecular diagnostics.
2.7. A new strategic approach to translational pathology is to be presented to the
Strategic Partnership Board in November 2013 and developed in conjunction with
the BRC Steering Committee, and the respective BRC Themes and Working
OUH-OU Joint Research Office
3.1 The OUH-OU Joint Research Office (JRO) was formed in May 2011, bringing
together the OU Medical Sciences Division Research Services Office (RSO),
Business Development Team and Clinical Trials Research Governance with OUH
R&D, OUH Contracts and R&D Finance and the BRC Management Team, colocated in refurbished space in the Churchill Hospital provided by OUH. The colocation of the JRO teams has greatly facilitated partnership working and
efficiency gains. The JRO now incorporates more than 80 staff (with over 60
qualified to first degree, 20 at masters level, 2 MBA and 17 to PhD), and the
added value of co-location attracts other groups, including research management
groups (e.g. cancer), NIHR Clinical Research Network Teams and external
3.2 Over the past year the focus of the operational development within the JRO has
been to align the functions of the above teams to increase efficiency of research
management. A major component of this work has been working with the Heads
of Teams to map out where joint working currently occurs, where it should be
encouraged and also where separation of function is a natural position between
two organisations.
3.3 The piece of work has now been completed and will culminate in an away day for
the JRO during which ‘improvement projects’ will be announced and planned to
deliver any changes to JRO business process as identified by the Heads of
3.4 In addition to this internal work, the University Deputy Director of research
services and the OUH Associate Director of R&D have met with other joint
research offices to learn from their experiences of setting up such an enterprise.
This has identified several models for a JRO and these are being considered
3.5 Space for accommodating any JRO expansion is already extremely limited.
Additional NIHR RCF funding to support a small expansion in accommodation,
working with OUH Estates is being directed towards medium term portacabin
accommodation. Greater synergies and external revenues, e.g. through
interaction with industry, could be realised if the JRO vision could be supported by
substantial provision of new space. The business development functions and
clinical research links with industry would be greatly enhanced by co-location of
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JRO groups, for example within the proposed Facilities Building and/or
BioEscalator projects. Inclusion of JRO functions within these new projects could
form an important component of the business plan.
3.6 The Board is asked to note proposals to develop OUH-OU partnership working
through the JRO in the Facilities Building and BioEscalator projects, to be
developed through TME and the Strategic Partnership Board.
New OUH Clinical Divisions Reconfiguration
4.1 The recent reconfiguration of the OUH Divisional structure, reducing the number
of clinical Divisions from seven to five, has important implications for partnership
working in clinical research. The two former OUH clinical Divisions incorporating
rheumatology and orthopaedics, and cardiac and vascular have now been
incorporated in other Divisions. Both of these clinical domains are important
components of the Musculoskeletal BRU, the Cardiovascular BRC Theme and for
engagement with the respective University Departments. Recent discussions
with the OUH CEO and Director of Clinical Operations have emphasised the
importance of maintaining prominence for musculoskeletal and cardiovascular
clinical research within the new re-configured OUH Divisional structure.
4.2 The reconfiguration of the OUH Clinical Divisions provides an opportunity to reemphasise the importance of clinical research management, governance and
performance. To ensure effective partnership working, it is proposed that each of
the five new OUH Divisional management groups should include two
representatives from respective OU MSD Departments, one of whom should also
be a BRC Theme Leader. The OU-OUH Joint R&D Committee has requested that
the OUH Clinical Divisions identify a Divisional R&D Lead who will take
responsibility for coordinating clinical research studies and ensuring satisfactory
performance in study initiation and recruitment.
4.3 The Board is asked to note plans to strengthen clinical research management,
governance and performance within each of the proposed OUH Divisional
Management Groups.
Clinical Research Performance Reporting:
5.1 The Government’s Plan for Growth, published in March 2011, aimed to increase
efficiency in initiation and delivery of clinical research, focusing on recruitment of
the first patient to clinical trials within 70 days of receiving a valid protocol – the
’70 Day Benchmark’; and delivery of commercial clinical trials to time and target.
5.2 NIHR has placed renewed emphasis on reporting metrics for the approvals and
initiation of clinical studies, which will be used for monitoring the R&D
performance of NHS Trusts. Attainment of key metrics is a requirement for NIHR
funding, including BRCs/BRUs, and performance metrics are published for each
NHS Trust receiving NIHR funding.
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5.3 All NHS Trusts in England receiving NIHR funding are required to submit
performance metrics to NIHR each quarter. The fifth quarterly report of data was
submitted on 30th July 2013. A summary of this submission is provided below.
Similar reports will be submitted to the Trust Management Executive on a
quarterly basis, with a recommendation that regular reports are submitted to the
Trust Board.
Summary of Performance for Q1 2013/2014
6.1 Performance should be considered in the context of the volume of research
undertaken at OUH (both as host and sponsor). The Trust is involved in approx.
1250 trials including over 20,000 patients, representing a significant challenge to
ensure all necessary approvals and performance. Nevertheless, there is a trend
of improvement; JRO staff continue to work with researchers to identify
efficiencies in R&D approvals and patient recruitment.
6.2 The 70 day Benchmark metric applies to all interventional trials and relates to the
time taken to set up a study and grant permission within a Trust (target 30
calendar days); and, once that permission has been granted, the time by the
investigator team to recruit the first patient (target 40 calendar days). Since the
beginning of the reporting period, the percentage of reported OUH studies
meeting the target timelines has shown gradual improvement. In the context of
metrics for all 48 NHS Trusts in England reporting to NIHR, published in October
2013, OUH ranks in ‘League 1’ (i.e. upper quartile) of Trusts based on number of
studies, and 5th position within this quartile in time to study initiation.
Q1 12/13
Q2 12/13
Q3 12/13
Q4 12/13
Q1 13/14
% meeting benchmark
6.3 Reasons for failure to meet these targets include some delays in initial approvals
and contract negotiations. However, failure to identify eligible patients for
recruitment after approval of the study is also a frequent cause for delay,
suggesting a lack of readiness, capacity or coordination with patient pathways for
conducting the research.
6.4 Commercial Trials Recruitment to Time and Target
This metric applies to trials with a commercial sponsor and relates to recruitment
numbers within the time period specified in the contract.
6.5 The number of trials reaching target recruitment by or before the target date has
shown no real improvement over the past three quarters, although OUH remains
one of the highest performing NHS Trusts for commercial studies recruitment.
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Q3 12/13
Q4 12/13
Q1 13/14
Number of reported
% meeting recruitment
6.6 From Q3 12/13, a marked change in reporting requirements and criteria was
introduced, making comparison between the first two quarters and later ones
difficult. As they lack equivalence with approximately 100 extra trials reported in
Q3 12/13, these figures have not been included within this table.
6.7 As mentioned above, one of the major factors contributing to the failure to meet
the 70 day benchmark is the recruitment of patients to trials.
6.8 The Joint Research Office is exploring measures to improve the clinical research
performance metrics, including:
6.8.1 Requiring researchers within the Trust and University to plan recruitment
of the first patient prospectively, and not to approach the Trust for NHS
permission until all arrangements with service support departments and
plans for study initiation are in place. These issues are to be overseen by
R&D leads within each of the OUH Clinical Divisions, reporting to the
Divisional Director.
6.8.2 Ensuring that projected recruitment is sufficiently feasible to enable
recruitment to time and target.
6.8.3 Giving consideration to withdrawal of Trust approval for studies where
research performance is persistently poor.
6.8.4 Consideration of new requests for NHS permission in the light of the
previous success of a Principal Investigator in achieving study initiation
and recruitment targets.
6.9 Improved operational support of clinical research studies will be required from
both OUH and OU teams within the Joint Research Office in order to achieve
these demanding performance targets. Potential sources of major delay in
study initiation include contract negotiations (typically undertaken by the OU
Research Services office), and clinical costings (required from OUH clinical
Directorates, Divisions, and clinical services such as laboratory medicine,
pharmacy and radiology).
Recruitment to clinical trials remains a challenge that needs to be addressed
on a Trust-wide basis, and can be addressed through the reconfiguration of
the OUH Divisions by appointment of Divisional R&D leads and ensuring that
clinical research performance metrics are an integral part of Divisional
performance management.
NIHR Local Clinical Research Networks
7.1 OUH is the host organisation for what is currently the Thames Valley
Comprehensive Local Research Network (CLRN), working closely both locally
and nationally with other disease specific networks to support research. OUH
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will, from April 2014, host the new Thames Valley and South Midlands Local
Comprehensive Research Network.
7.2 The CLRN has overachieved against recruitment objectives, with 28,846 recruits
over the 5 year period, well in excess of the CCRN target to double activity. In
2012/13 this comprised recruitment to 518 different studies across 13 NHS trusts.
OUH is listed in the recently released Guardian League Table as second highest
recruiting NHS Trust nationally, with over 16,000 recruits.
7.3 The CLRN is also subject to NIHR performance monitoring, with a focus on
RM&G, and has achieved consistent progress. The CLRN overachieved the
median target performance required for the complete 2012/13 financial year both
for local and study wide checks, with reported 2012/13 mean timelines of 24 days
and 21 days respectively.
7.4 The commercial study activity in the TVCLRN portfolio has grown significantly
during the year, reflecting the emphasis we have placed on supporting the Life
Sciences Industry and the expansion of local Specialties. As at year end, the
CLRN achieved its highest ranking to date (3rd) in the Commercial Open Study
Performance ranking and is now ranked 5th in Network-Supported Sites for
Studies that Closed in 2012/13.
7.5 The OUH competed successfully in the recent national competition to host the
new NIHR Local Clinical Research Network (LCRN), being designated the Host
Organisation for the Thames Valley & South Midlands LCRN from April 2014.
7.6 The new LCRN replaces the existing Thames Valley Local Comprehensive
Research Network (TVCLRN) and topic-specific networks in Diabetes, Stroke,
Cancer and Neurodegeneration (DENDRON), incorporating these activities in to 6
new clinical research divisions covering all therapeutic areas. The LCRN depends
on participation from all NHS Trusts across the LCRN region, which is coincident
with the Oxford AHSN, but the governance and responsibility for the management
and performance of the LCRN rests with the Board of Host Organisation, working
through a designated Executive Director (the OUH Medical Director), and the
LCRN Clinical Director and Chief Operating Officer. An operational manager
‘Transition Lead’ has been appointed by NIHR to facilitate the transition from the
existing NIHR networks to the new LCRN. The new management arrangements
and indicative budget allocations pose some particular challenges for the OUH
and the new LCRN, which have been brought to the attention of Dr. Jonathan
Sheffield, CEO of the NIHR LCRNs.
R&D Finance
8.1 The R&D Finance team provides management accounting and business support
services to those researchers undertaking or applying to undertake research
activity within OUH. The team manages circa £45m of R&D Funding annually
within the Trust and a further £5m of funding in the role of as NIHR Thames
Valley Network Hosting Trust.
8.2 Specifically, the team provides management accounting and business support
functions for a range of different funding streams, including, BRC, BRU, Clinical
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Research Facilities (CRFs), NIHR Research Capability Funding (RCF), NIHR
Networks (both as host and participant), Study & Grant Funding, Commercially
funded studies.
8.3 Research Capability Funding (RCF)
8.3.1 As a result of its success in attracting NIHR funding, OUH received
£5.5m of NIHR RCF in 2012-13. Over the past year, R&D staff have
worked very closely with OUH Director of Finance, and colleagues, to
develop models of financial management that has allowed OUH to use
these funds to support strategic initiatives, greatly enhancing the
potential for growth of research within the Trust.
8.3.2 RCF is distributed in a structured way:
£2.2m has been provided to underpin research efforts and costs
within the Trust. In addition, researchers are able to apply for
modest support from RCF on an ad hoc basis.
A call for proposals was made for applications for strategic
recruitment across the partnership and the first round has just
completed. RCF funds will be used to support these key
In October 2013, a call was opened for proposals to fund
specific research activities, in keeping with NIHR criteria for the
use of RCF, during 2014/15.
8.4 Costings model
Members of the OUH R&D team are currently undertaking a review of costs of
research across the Trust, included working with the PLICS initiative. This project
seeks to identify the baseline costs for research activities in the Trust to support
grant applications and attracting industry research in an increasingly competitive
market. The costing model aims to provide more accurate and rapid
reimbursement of research costs within the OUH Divisions, and support of core
research infrastructure and support.
Professor Edward Baker
Medical Director
Report prepared by:
Professor Keith Channon
Director of R&D
October 2013
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